OINDP Clinical Development
Preparing your new intranasal or inhaled drug product for clinical trials can have a major impact on its overall development timeline. Oversights in the early stages of development can derail progress of even the most promising of OINDPs. Nanopharm’s dedication to developing inhaled and intranasal drug products has equipped it with the complete capabilities to progress your product through clinical stages and eliminate the hassle of coordinating multiple CROs or CDMOs.
Nanopharm Clinical Development Services
Nanopharm has the know-how, network, and capabilities to take OINDP products to the clinic. Our analytical team of respiratory specialists can develop and qualify OINDP analytical test methods and then provide phase appropriate validation in our cGMP laboratories, and ultimately test your OINDP batch for release into the clinic. Nanopharm has partnered with several highly qualified contract manufacturing organizations (CMOs) to support the manufacturing of your specialized OINDP products for early clinical studies, with specialized equipment and capabilities for filling and assembling Aptar’s OINDP intranasal or inhaled drug product delivery systems. We take a holistic view of your development program and have the expertise to advance you to the clinic seamlessly.
Nanopharm manages qualified specialist CMO partners to manufacture intranasal and inhaled drug product clinical trial materials (CTM) for early phase studies with proprietary equipment for the specialized filling and assembly of Aptar drug delivery systems.
Nanopharm’s analytical release and stability testing is exclusively focused on inhaled and intranasal drug products utilizing and array of specialized analytical techniques in our cGMP qualified laboratory.
Nanopharm makes clinical trial materials (CTM) manufacturing simple for customers through our long-standing partnerships with CMOs that specialize in small scale cGMP manufacturing of OINDPs. Nanopharm leverages its trusted relationships with the qualified CMOs so you don’t have to contract and manage another third party. We manage the technical transfer process of products Nanopharm has developed, and support oversight of the manufacturing process for a smooth and timely production process. Our CMO partners can provide manufacturing services for a range of device and formulation types, whether they are traditional small molecule or sensitive biologics. From dry powder inhalers (DPIs), pressurized metered-dose inhalers (pMDIs), nasal sprays to nebulizers, Nanopharm can deliver CTM manufacturing services that deliver with agility and speed for early phase cGMP studies.
Nanopharm’s analytical laboratory provides cGMP release and stability testing for intranasal and inhaled drug products. Our analytical laboratories develop specialized test methods specifically for our customer products from the earliest stages of development, and then perform stage appropriate qualifications and validations. Nanopharm’s analytical cGMP laboratory can perform efficient OINDP testing for clinical trial materials and perform accelerated or long-term stability testing. Customers requiring release testing and stability testing at late stage clinical or even commercial stages can rely on Nanopharm’s OINDP analytical experts.
Nanopharm cGMP Analytical Release and Stability Testing Solutions
Nanopharm’s specialized clinical development services prepare your latest OINDP product for the clinic. We can engage and manage qualified CMO partner organizations to efficiently produce your early phase cGMP clinical trial materials (CTMs) so you don’t need to seek manufacturers on your own and potentially find yourself in long queues. Our cGMP laboratories can provide stage appropriate analytical method validations and testing services for both CTM release and stability programs so you can advance your OINDPs faster and with confidence.
